Direct-to-Consumer Advertising of Prescription Drugs

Direct-to-Consumer Advertising of Prescription Drugs

Date: May 20, 2009
Creator: Thaul, Susan
Description: This report describes the current status of direct-to-consumer (DTC) drug advertising; analyzes issues surrounding it; and discusses potential options for Congress.
Contributing Partner: UNT Libraries Government Documents Department
Smallpox Vaccine Injury Compensation

Smallpox Vaccine Injury Compensation

Date: June 13, 2003
Creator: Thaul, Susan
Description: This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
Contributing Partner: UNT Libraries Government Documents Department
Pharmaceutical Supply Chain Security

Pharmaceutical Supply Chain Security

Date: October 31, 2013
Creator: Thaul, Susan
Description: This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Contributing Partner: UNT Libraries Government Documents Department
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Date: December 2, 2008
Creator: Thaul, Susan
Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Contributing Partner: UNT Libraries Government Documents Department
Vaccine Policy Issues

Vaccine Policy Issues

Date: May 19, 2005
Creator: Thaul, Susan
Description: None
Contributing Partner: UNT Libraries Government Documents Department
H.R. 6: The 21st Century Cures Act

H.R. 6: The 21st Century Cures Act

Date: July 8, 2015
Creator: Johnson, Judith A.; Thaul, Susan & Bagalman, Erin
Description: Report about H.R. 6, the 21st Century Cures Act, which would reauthorize the National Institutes of Health (NIH) through FY2018 and provide other funding to the agency through FY2020.
Contributing Partner: UNT Libraries Government Documents Department
Importing Prescription Drugs: Objectives, Options, and Outlook

Importing Prescription Drugs: Objectives, Options, and Outlook

Date: August 4, 2004
Creator: Thaul, Susan & Vogt, Donna U
Description: None
Contributing Partner: UNT Libraries Government Documents Department
The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Description: This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Contributing Partner: UNT Libraries Government Documents Department
The FDA 2009 Budget Request

The FDA 2009 Budget Request

Date: May 19, 2008
Creator: Johnson, Judith A.; Lister, Sarah A.; Porter, Donna V.; Smith, Pamela W.; Thaul, Susan & Williams, Erin D.
Description: The Administration's FY2009 budget request of $2.4 billion for the Food and Drug Administration (FDA) would provide a 5.7% increase ($130 million) over FY2008. User fees would make up about 26% of the total amount requested and would account for 61% of the proposed increase. Budget documents indicate that the additional funding would provide for expanded activities to ensure the safety of foods and drugs, as well as to accelerate the availability of new medical products. About half of the requested increase would be used for cost-of-living pay increases, as opposed to new program activities.
Contributing Partner: UNT Libraries Government Documents Department